Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Catalys Precision Laser System-Catalys - U - US product Recalled by Optimedica Corporation Due to Software anomaly on OptiMedica CATALYS System version 3.00.05...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Optimedica Corporation directly.
Affected Products
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Quantity: 171 distributed Worldwide
Why Was This Recalled?
Software anomaly on OptiMedica CATALYS System version 3.00.05 that may result in incorrect parameters provided for cataract incision surgeon templates and both eyes have the same parameters.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Optimedica Corporation
Optimedica Corporation has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report